Environmental factors predictive of misbehavior in collaborative health research

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DESCRIPTION (provided by applicant): Project Summary of the R21 proposal, "Environmental factors predictive of misbehavior in collaborative health research." Misbehavior in health research -- such as fabricating research data, fraudulent billing, or withholding information about known risks from research participants-adversely affects the health care economy and undermines patient trust, which in turn contributes to health disparities and reluctance to enroll in clinical trials. This project proposes to use historiometric methods (described below) to identify environmental factors that predict severe misbehavior in collaborative health research. Environmental factors include factors such as secrecy, conflicting roles, rewards for misbehavior, ambiguous professional norms, failures of oversight, and being in a position of authority. The long-term aim of this project is to improve research ethics education programs, research policies, and oversight practices by increasing understanding of the actual factors that influence misbehavior in research. The 4 specific aims of the project include: [1] To extract data from at least 90 published cases of misbehavior in collaborative research to generate case summaries that include descriptive data on the key protagonist, the misbehavior, the outcomes of the event, and 12 environmental factors hypothesized to correlate with research misbehavior. We will use purposive criterion and heterogeneity sampling methods to obtain cases. To be included, cases must involve health science research in the US from 1900 or later; cases must be at least 1 year old (to ensure adequate reporting opportunity) and be described in at least 3 independent published accounts. We will further seek out cases representing a broad spectrum of severity of misbehavior, with a variety of kinds of misbehavior represented (e.g., we will not focus just on fraud or narrow misconduct cases), and cases involving differing levels of collaboration. [2] To use correlation and linear regression models to test the relationship of environmental factors (predictor variables) and the severity of misbehavior (target variable). Independent research ethics experts will score the severity of misbehavior in each case using a score sheet developed by the research team; 2 research assistants will score the presence of environmental factors using a benchmark score sheet. [3] To test the relationship between the severity of misbehavior in research to 2 forms of collaboration: (a) multisite collaboration among multiple PIs and (b) interdisciplinary collaboration (studies involving key personnel from different disciplines). If collaboration is predictive of less severe or more severe misbehavior, then we will examine whether the variable operates in isolation or rather through the mediation of other variables such as "ambiguous professional norms." [4] To publish articles that explore the practical implications of our findings for RCR education, RCR policies, and oversight practices. PUBLIC HEALTH RELEVANCE (provided by applicant): Project Narrative for the R21 proposal, "Environmental factors predictive of misbehavior in collaborative health research." Misbehavior in health research-such as fabricating research data, fraudulent billing, or withholding information about known risks from research participants-adversely affects the health care economy and undermines patient trust, which in turn contributes to health disparities and reluctance to enroll in clinical trials. The long-term aim of this project is to improve research ethics education programs, research policies, and oversight practices by increasing understanding of the actual factors that influence misbehavior in research.